Stability trials

ALS is a one stop shop for your stability trial design, storage, analysis and data trending.

Being an essential component of pharmaceutical development, stability studies allow the evaluation of product stability under the influence of various environmental conditions. These include temperature, humidity and light, simulating different climatic zones from around the world. The data from such studies can be used by the client to establish recommended storage conditions, retest periods and shelf life.

Our purpose-built walk-in stability rooms are fully validated to meet GMP regulations and can be utilised for both long term and short-term shelf life studies. All rooms are monitored in real time and we operate emergency back-up facilities on site, allowing business continuity and complete peace of mind for our clients.

We can provide a solution tailored to your requirements - storage only or full storage plus testing. Samples can be stored and scheduled for testing or shipped to your chosen location at each time point or as required.

Security

All chambers are kept locked, with restricted access

Audible and visual alarms for temperature and humidity (above and below set conditions)

Data loggers have email and auto dial alert functionality

UPS on data logger ensuring continuous monitoring and alarm call outs

Definition of Zones

Zone I:Temperate climate

Zone II:Subtropical and Mediterranean climate

Zone III:Hot and dry climate

Zone IVa:Hot and humid climate

Zone IVb:Hot and very humid climate

Stability Storage Conditions Available

5ºC

Long term conditions for cold stored products or retained/control samples

25ºC/60%RH

Long term conditions for climatic zones I and II

30ºC/65%RH

Intermediate and long term conditions for climatic zones I, II,III and IVa